A Pilot of a Personalized Circadian mHealth to Improve Sleep in Night Shift Workers

Part of paid clinical trials in Novi, Michigan.

Sponsor
Henry Ford Health System
Study ID
NCT06809335
Status
Recruiting

Conditions

  • Shift Work Sleep Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personalized circadian mHealth — OTHER
    SHIFT is a mobile application designed to improve sleep in night shift workers. The SHIFT mobile application is used to collect data from an Apple Watch to assess an individual shift worker's body-clock timing and make personalized recommendations of light exposure schedules that are designed to align the body-clock with the night shift work schedule.

Study Details

The goal of this project is to establish the evidence base for equitable accessibility and implementation of the precision sleep medicine mobile application, SHIFT.

Key Dates

Start date
Oct 23, 2023
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHIFT App
    Participants in this condition will receive an access code to download the mobile application and conduct an orientation to SHIFT and the study procedures with a study team member. They will then enter four weeks of study directed use of SHIFT where they are trained on a daily procedure of opening SHIFT at the beginning of their day and planning their day in accordance with the app recommendations. App usage (4 times per week) will be incentivized with weekly bonuses added to study compensation. Following the four weeks of study-directed use, participants will continue with self-directed use. At four months, participants will then complete a booster session with two additional weeks of study-directed use, followed by self-directed use until the end of the study. The structure with the booster session has evidence for maintaining treatment gains and is also in alignment with the commercialization plan.
  • No Intervention: Waitlist Control
    Participants in this condition will only complete questionnaires for the initial eight months. Those who remain shift workers will have the option of receiving the SHIFT app and the option to complete follow-up surveys in the same manner as the SHIFT App condition.

Primary Outcome Measure

Establish the effect of SHIFT on stakeholder-centered outcomes. [ Time Frame: From enrollment to the 8 month point. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Henry Ford Columbus Medical CenterNoviMichigan48377
Philip Cheng, PhD
248-344-7361
Marleigh Treger, BS
248-344-8028

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